MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G148

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

As no further information related to this report is expected, our investigation is complete.This report will be updated should further information become available.

Event Description

It was reported that this delivered eight shocks in one episode.There were also additional episodes noted on the same day.Attempts to obtain additional information from a representative were unsuccessful, therefore no confirmation that therapy was still available was received.No adverse patient effects were reported.

Manufacturer Narrative

As no further information related to this report is expected, our investigation is complete.This report will be updated should further information become available.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this delivered eight shocks in one episode.There were also additional episodes noted on the same day.Attempts to obtain additional information from a representative were unsuccessful, therefore no confirmation that therapy was still available was received.No adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9886711
• MDR Text Key: 185254908
• Report Number: 2124215-2020-03575
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 134102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male